Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078581
Company: SUN PHARM INDUSTRIES

Products on ANDA 078581

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TEMAZEPAM	TEMAZEPAM	7.5MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078581

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/08/2009	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/26/2021	SUPPL-10	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
08/12/2019	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
08/12/2019	SUPPL-7	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
02/04/2011	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 078581

TEMAZEPAM

CAPSULE;ORAL; 7.5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
RESTORIL	TEMAZEPAM	7.5MG	CAPSULE;ORAL	Prescription	Yes	AB	018163	SPECGX LLC
TEMAZEPAM	TEMAZEPAM	7.5MG	CAPSULE;ORAL	Prescription	No	AB	211542	ALEMBIC
TEMAZEPAM	TEMAZEPAM	7.5MG	CAPSULE;ORAL	Prescription	No	AB	217875	ALKEM LABS LTD
TEMAZEPAM	TEMAZEPAM	7.5MG	CAPSULE;ORAL	Prescription	No	AB	203482	AMNEAL PHARMS
TEMAZEPAM	TEMAZEPAM	7.5MG	CAPSULE;ORAL	Prescription	No	AB	071457	NOVEL LABS INC
TEMAZEPAM	TEMAZEPAM	7.5MG	CAPSULE;ORAL	Prescription	No	AB	201781	PRINSTON INC
TEMAZEPAM	TEMAZEPAM	7.5MG	CAPSULE;ORAL	Prescription	No	AB	078581	SUN PHARM INDUSTRIES